Donor Derived CD117 CAR-T Cells in the Treatment of R/R Acute Myeloid Leukemia

Zhejiang University

Status and phase

Enrolling

Early Phase 1

Conditions

Acute Myeloid Leukemia

Treatments

Biological: CD117 CAR T-cells

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07144020

TXB2024010

Details and patient eligibility

About

A Clinical Study on the Safety and Effectiveness of Donor Derived CD117 CAR-T Cell in the treatment of Relapsed/Refractory Acute Myeloid Leukemia

Full description

This is a single-arm, open-label, dose-escalation clinical trial to evaluate the safety and efficacy of CD117 CAR-T Cell in patients with relapsed or refractory acute myeloid leukemia. It is planned to enroll 15-50 participants in this trial.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Patients with a histologically or immunophenotypically confirmed diagnosis of CD117-positive Acute Myeloid Leukemia (AML).
2. Diagnosis must meet the 2016 WHO classification criteria for AML and fulfill the definitions for relapsed or refractory disease per the *Chinese Guidelines for the Diagnosis and Management of Relapsed/Refractory Acute Myeloid Leukemia (2017 Edition)*, with no available suitable standard therapeutic options or registered clinical trials.
a). Relapsed AML: Defined as the reappearance of leukemic blasts in the peripheral blood, bone marrow blast count >5% (when assessed morphologically, after excluding regenerative changes post-consolidation chemotherapy), or development of extramedullary disease after achieving a Complete Remission (CR).
b). Refractory AML (meeting at least one criterion): Failure to achieve CR following two cycles of standard induction therapy in newly diagnosed patients; relapse within 12 months after CR following consolidation therapy; relapse beyond 12 months that fails to respond to conventional salvage chemotherapy; ≥2 relapses; or persistent extramedullary leukemia.
3. Presence of >5% bone marrow blasts (by morphology) and/or >1% (by flow cytometric analysis).
4. Total bilirubin ≤1.5 × ULN (≤51 μmol/L) ALT and AST ≤3 × ULN Serum creatinine ≤1.5 × ULN (≤176.8 μmol/L)
5. Left ventricular ejection fraction (LVEF) ≥50% as assessed by echocardiography.
6. Oxygen saturation ≥92% on room air.
7. Life expectancy ≥3 months.
8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
9. For patients of childbearing potential: Agreement to use highly effective contraception from screening, throughout the study treatment period, and for at least 6 months after the cell infusion (due to unknown risks to the fetus).
10. Voluntary participation, understanding of the study procedures, and provision of written informed consent by the patient or their legally authorized representative.

Exclusion criteria

1. Patients with the history of epilepsy or other CNS disease;
2. Patients with prolonged QT interval time or severe heart disease;
3. Active infection with no cure;
4. Active infection of hepatitis B virus or C virus ;
5. Before using any gene therapy products;
6. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
7. Suffering from other uncontrolled diseases that the researchers consider unsuitable for joining;
8. Infected with AIDS virus;
9. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.